Clonidine and Morphine in Caudal Anesthesia

March 18, 2010 updated by: Federal University of Minas Gerais

Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery

Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, submitted to urogenital surgery, under general anesthesia and caudal block. The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine, bupivacaine plus morphine, bupivacaine plus clonidine and morphine. The peroperative consumption of analgesics and inhaled gases, BIS, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using Wong-Baker faces scale and pain and discomfort score scale, as well as the consumption of analgesics.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • Santa Casa de Belo Horizonte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Urogenital pediatric surgery
  • Status physical(ASA) 1 and 2

Exclusion Criteria:

  • Cutaneous infection in puncture site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both
Drug: Bupivacaine
Caudal anesthesia with bupivacaine 0,166% 1 ml/kg
Active Comparator: C
compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine
Drug: Clonidine
1 mcg/kg
Active Comparator: M
compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine
Drug: Morphine
20 mcg/kg
Active Comparator: CM
compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine
Drug: Bupivacaine plus clonidine and morphine

bupivacaine 0,166% 1 ml/kg

clonidine 1 mcg/kg

morphine 20 mcg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The overall postoperative consumption of analgesics.
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The peroperative consumption of volatile anesthetics.
Time Frame: 3 hours
3 hours
The peroperative Bispectral Index measure.
Time Frame: 3 hours
3 hours
Postoperative Wong-Baker faces scale
Time Frame: 24 hours
24 hours
Postoperative pain and discomfort score scale
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Collaborators

Santa Casa de Misericórdia de Belo Horizonte

Investigators

  • Study Director: Renato S Gomez, PhD, MD, Federal University of Minas Gerais
  • Principal Investigator: Magda L Fernandes, M, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 2, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Estimate)

March 19, 2010

Last Update Submitted That Met QC Criteria

March 18, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 210665

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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